System and method for all-inside suture fixation for implant attachment and soft tissue repair

ABSTRACT

In one embodiment, the present invention is a system for repairing a meniscus including: a suture assembly including a first anchor, a second anchor, and a flexible suture connecting the first anchor and the second anchor, the flexible suture including a slide knot between the first anchor and the second anchor; and an inserter including a needle having a longitudinal extending bore and an open distal end, the bore being configured to receive the first anchor and the second anchor, a housing operatively connected to a proximal end of the needle, the housing having a lumen and a slot, the slot including a first portion, a second portion, a first shoulder and a second shoulder and a pusher configured to rotate and slide within the lumen of the housing and the longitudinal extending bore of the needle, the pusher having an extension extending through the slot and configured to be maneuverable through the first portion and second portion and engageable with the first shoulder and second shoulder.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing date of U.S.Provisional Patent Application No. 62/341,744 filed May 26, 2016, andU.S. Provisional Patent Application No. 62/370,167 filed Aug. 2, 2016,both of which are incorporated herein by reference herein as if fullyset forth herein.

FIELD OF THE INVENTION

The present invention relates generally to a system and method forreducing or bringing into close approximation, generally referred to asre-approximation herein, pieces of torn or damaged soft tissue tofacilitate tissue repair and healing, and/or for attaching an implantduring soft tissue repair, such as in meniscal repair or replacement.More particularly, the present invention relates to a system and methodfor an all-inside suture fixation device and method designed for theplacement of surgical anchors.

BACKGROUND OF THE INVENTION

There are current instruments and systems on the market for use inrepairing torn or damaged soft tissue, such as a torn meniscus. However,such devices have various drawbacks. For example, current systems on themarket utilize needles and implants that have a comparatively largecross-section which damage the tissue during implantation. Further, suchsystems can be difficult to use in that an operator, such as a surgeon,must utilize higher forces than should be required to position theneedle and implant the anchors. Such systems include the FAST-FIX™ andRAPIDLOC™.

Similarly, such devices are used in procedures for surgical attachmentof a soft tissue implant in a joint, such as an autograft, allograft, orxenograft tissue or other compatible tissues and/or devices. Suchimplants may be bioresorbable and/or non-resorbable, synthetic and/ornon-synthetic. One example of a bioresorbable implant is the CMI™ (IvySports Medicine LLC (a division of Stryker Orthopedics), Redwood City,Calif.), a collagen-based meniscus implant, the surgical attachment ofwhich can involve techniques that are difficult to master. Theabove-mentioned systems similarly have limitations in these proceduresbecause, in their delivery of anchors to attach an implant to themeniscal rim, they may cause unnecessary destruction to the implant. Theneedle used to pass the anchor through an implant and through themeniscal rim punctures the implant in a manner that may lead to tearingof the implant matrix.

There is a need, therefore, for a dimensionally smaller device thatemploys a needle and anchors that are less destructive on surroundingtissue and/or an implant, if present. Further, there is a need for asystem that is more user-friendly and adaptable for each surgeon'sparticularities and surgical setup.

BRIEF SUMMARY OF THE INVENTION

One embodiment of the present invention includes a system for repairinga meniscus, including a suture assembly including a first anchor, asecond anchor, and a length of suture connecting the first anchor andthe second anchor, the suture including a slide knot along its lengthbetween the first anchor and the second anchor, and an inserter, theinserter including a needle having a longitudinal extending bore and anopen distal end, the bore being configured to receive the first anchorand the second anchor, a housing operatively connected to a proximal endof the needle, the housing having a lumen and a slot, the slot includinga first portion, a second portion, a first shoulder and a secondshoulder, and a pusher configured to rotate and slide within the lumenof the housing and the longitudinal extending bore of the needle, thepusher having an extension extending through the slot and configured tobe maneuverable through the first portion and second portion andengageable with the first shoulder and second shoulder.

In another embodiment, the present invention includes an instrument forrepairing a meniscus including a needle having a longitudinal extendingbore and an open distal end, a housing operatively connected to aproximal end of the needle, the housing having a lumen, a slot includinga first portion, a second portion, a first shoulder and a secondshoulder, and a first grip and a second grip, and a pusher configured torotate and slide within the lumen of the housing and the longitudinalextending bore of the needle, the pusher having an extension extendingthrough the slot and configured to be maneuverable through the firstportion and second portion and engageable with the first shoulder andsecond shoulder.

In a further embodiment, the present invention includes a system forrepairing a meniscus, including a suture assembly including a firstanchor, a second anchor, and a flexible suture connecting the firstanchor and the second anchor, the flexible suture including a slide knotbetween the first anchor and the second anchor, and an inserter,including a needle having a longitudinal extending bore and an opendistal end, the bore being configured to receive the first anchor andthe second anchor, a housing operatively connected to a proximal end ofthe needle, the housing having a lumen, a pusher configured to rotateand slide within the lumen of the housing and the longitudinal extendingbore of the needle, and a sheath releasably secured to the housing by apress-fit engagement and having a lumen, the needle being positionablewithin the lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

Features of the invention are shown in the drawings, in which likereference numerals designate like elements. The drawings form part ofthis original disclosure, in which:

FIG. 1 is a side view of an embodiment of a system for all-inside suturefixation for implant attachment and soft tissue repair of the presentinvention;

FIG. 2 is a top view of an embodiment of a needle of the system of FIG.1;

FIG. 3 is a side view of the needle of FIG. 2;

FIG. 4 is a cross-sectional view taken along line 4-4 in FIG. 2;

FIG. 5 is a side view of another embodiment of the needle for the systemof FIG. 1;

FIG. 6 is a top view of the needle of FIG. 5;

FIG. 7 is a cross-sectional view taken along line 7-7 in FIG. 6;

FIG. 8 is a side view of a pusher of the system of FIG. 1;

FIG. 9 is a top view of an anchor of a suture of the system of FIG. 1;

FIG. 10 is an end view of the anchor of FIG. 9;

FIG. 11 is a side view of the anchor of FIG. 9;

FIG. 12 is a top view of another embodiment of an anchor of the suturefor the system of FIG. 1;

FIG. 13 is an end view of the anchor of FIG. 12;

FIG. 14 is a side view of the anchor of FIG. 12;

FIG. 15 is a view of an anchor threaded onto a suture of the system ofFIG. 1;

FIG. 16 is a view of the anchor and suture of FIG. 15 with a loop and aself-locking slide knot formed in the suture;

FIG. 17 is a view of the anchor and suture of FIG. 16 with a secondanchor positioned on the suture;

FIG. 18 is a partial view of the second anchor and suture of FIG. 17;

FIG. 19 is a partial view of the second anchor and suture of FIG. 17with a needle threaded on the suture;

FIG. 20 is a partial view of the needle threaded on the suture andpassing through the center of the suture at the second anchor;

FIG. 21 is a partial view of the needle passing through the center ofthe suture at the second anchor a second time;

FIG. 22 is a view of the anchor with a knot securing it to the suture;

FIG. 23 is a partial view of the suture and the second anchor at one endthereof;

FIG. 24 is a perspective view of a meniscus with an implant positionedon the meniscus;

FIG. 25 is a view of the implant after it has been secured to theremaining surrounding soft tissue, such as meniscus;

FIG. 26 is a view of the suture and anchor configuration of the systemof FIG. 1;

FIG. 27 is a top view of the needle with the pusher extended therefrom;

FIG. 28 is a side view of the suture being threaded into the pusher andthe needle;

FIG. 29 is a side view of the suture further being threaded into thepusher and the needle;

FIG. 30 is a top view of the needle with the suture loaded therein;

FIG. 31 is a side view of the needle of FIG. 30;

FIG. 32 is a top view of the needle of the system of FIG. 1 piercing theimplant and meniscus of FIG. 25 at a first location;

FIG. 33 is a top view of the needle of FIG. 32 after the first anchorhas been deployed from the needle with the pusher;

FIG. 34 is a perspective view of the needle of FIG. 32 after it has beenpulled back through the meniscus and implant;

FIG. 35 is a top view of the needle of FIG. 32 piercing the implant andremaining surrounding soft tissue, such as meniscus, of FIG. 25 at asecond location;

FIG. 36 is a top view of the needle of FIG. 35 after the second anchorhas been deployed from the needle with the pusher;

FIG. 37 is a top view of the needle of FIG. 35 after is has been pulledback through the meniscus and implant;

FIG. 38 is a top view of the needle of FIG. 37 with the pusher extendedout of the needle;

FIG. 39 is a top view of the needle of FIG. 38 with the pusher pushingthe knot against the implant;

FIG. 40 is a top view of the needle of FIG. 39 after it has been pulledback following knot pushing and suture tensioning;

FIG. 41 is a side view of the needle of FIG. 40 with the suture exposedto the needle cutting surface;

FIG. 42 is a side view of another embodiment of the needle of FIG. 40with the suture exposed to a cutting surface on a cutting sheath;

FIG. 43 is a top view of the repaired meniscus with the suture tightlyin place;

FIG. 44 is a side view of another embodiment of a system for all-insidesuture fixation for implant attachment and soft tissue repair of thepresent invention;

FIG. 45 is a proximal end view of a body portion of the system of FIG.44;

FIG. 46 is a side view of an embodiment of a pusher of the system ofFIG. 44;

FIG. 47 is a cross-sectional view of the pusher taken along line 47-47in FIG. 46;

FIG. 48A is a side view of a proximal end of the pusher of FIG. 46 in afirst position relative to the body portion;

FIG. 48B is the proximal end view of the body portion with a portion ofthe pusher in the first position of FIG. 48A;

FIG. 48C is a side view of a needle of the system of FIG. 44 and adistal end of the pusher, with the pusher in the first position of FIG.48A;

FIG. 49A is a side view of the proximal end of the pusher of FIG. 46 ina second position relative to the body portion;

FIG. 49B is the proximal end view of the body portion with a portion ofthe pusher in the second position of FIG. 49A;

FIG. 49C is a side view of the needle and the distal end of the pusher,with the pusher in the second position of FIG. 49A;

FIG. 50A is a side view of the proximal end of the pusher of FIG. 46 ina third position relative to the body portion;

FIG. 50B is the proximal end view of the body portion with a portion ofthe pusher in the third position of FIG. 50A;

FIG. 50C is a side view of the needle and the distal end of the pusher,with the pusher in the third position of FIG. 50A;

FIG. 51A is a side view of the proximal end of the pusher of FIG. 46 ina fourth position relative to the body portion;

FIG. 51B is the proximal end view of the body portion with a portion ofthe pusher in the fourth position of FIG. 51A;

FIG. 51C is a side view of the needle and the distal end of the pusher,with the pusher in the fourth position of FIG. 51A;

FIG. 52A is a side view of the proximal end of the pusher of FIG. 46 ina fifth position relative to the body portion;

FIG. 52B is the proximal end view of the body portion with a portion ofthe pusher in the fifth position of FIG. 52A;

FIG. 52C is a side view of the needle and the distal end of the pusher,with the pusher in the fifth position of FIG. 52A;

FIG. 53A is a side view of the proximal end of the pusher of FIG. 46 ina sixth position relative to the body portion;

FIG. 53B is the proximal end view of the body portion with a portion ofthe pusher in the sixth position of FIG. 53A;

FIG. 53C is a side view of the needle and the distal end of the pusher,with the pusher in the sixth position of FIG. 53A;

FIGS. 54 and 55 are schematic views showing an embodiment of a systemformed in accordance with the present invention, wherein the systemincludes an anchor assembly and an inserter.

FIG. 56 is another illustration of the embodiment of FIGS. 54 and 55where the housing of the inserter is transparent for ease ofillustration.

FIGS. 57-59 illustrate a schematic of the distal portion of the inserterand the anchor assembly and further wherein portions of the anchorassembly (i.e., the terminus knot and the slip knot) are shown inschematic form for clarity of illustration;

FIGS. 60-70A are schematic views showing further details of the anchorassembly of the system of FIGS. 54-59, wherein the terminus knot and theslip knot are shown in schematic form in FIG. 60 for clarity ofillustration, and further wherein certain variations of the terminusknot and the slip knot are shown in line drawings in FIGS. 61, 68-70 and68A-70A;

FIGS. 71-75 are schematic views showing further details of the inserterof the system of FIGS. 54-59, specifically the proximal portions of theinserter;

FIGS. 76-82 illustrate exemplary uses of the system of FIGS. 54-59.

DETAILED DESCRIPTION

U.S. patent application Ser. No. 13/410,501, filed Mar. 2, 2012, U.S.patent application Ser. No. 11/501,235, filed Aug. 9, 2006, U.S. patentapplication Ser. No. 11/348,467, filed Feb. 7, 2006, and U.S.Provisional Patent Application Ser. No. 60/650,131, filed Feb. 7, 2005,are hereby incorporated herein by reference as if fully set forthherein.

A system 1 for repairing soft tissue, such as for example a meniscus,according to an embodiment of the present invention is illustrated inFIG. 1. The system 1 includes an applicator 10 that is constructed andarranged to deploy a suture 12 to soft tissue, such as the meniscus. Thesuture 12 generally includes a flexible length of suture material 58 andincludes a pair of anchors 60, 70 positioned thereon. The suture 12 willbe discussed in greater detail below.

The applicator 10 includes a body portion 14 that defines a handle 16that is configured to be grasped by the user. The body portion 14 of theapplicator 10 receives a cannula 18 that extends from the body portion14 in a direction that is away from the handle 16. The body portion 14and cannula 18 may be constructed and arranged like those described andshown in U.S. Pat. No. 5,928,252, which is incorporated herein byreference in its entirety. Because the inner workings of the bodyportion 14 are not related to the present invention, they are notdescribed in detail herein.

The applicator 10 also includes a needle 20 that is connected to adistal end of the cannula 18. Of course, the needle 20 may be consideredto be a part of the cannula 18 itself. The needle 20 will be describedin greater detail below. The applicator 10 also includes a pusher 23that includes a hollow rod 24 that extends through the body portion 14,the cannula 18, and is slidingly received by the needle 20. A knob 26 isattached to one end of the rod 24 and a spacer 28 with a tab 29 isdisposed between the knob 26 and a proximal end 15 of the body portion14 so that the movement of the knob 26 relative to the body portion 14and, hence, movement of the rod 24 relative to the needle 20, may belimited to prevent premature deployment of one of the anchors 60 priorto the placement of the other anchor 70, as described in further detailbelow. A trigger 30 is connected to and extends from the body portion14, as shown in FIG. 1. The trigger 30 is configured to manually controlthe advancement of the rod 24 within the cannula 18. A side lever 32 isconnected to the body portion so as to be pivotable thereon. Operationof the side lever 32 will be discussed in greater detail below.

As shown in FIG. 1, a depth penetration limiter 21 is placed over thedistal end of the cannula 18 so as to partially cover the needle 20. Thelimiter 21 provides the user with a visualization of the depth of theneedle 20 in the tissue to avoid neurovascular injury. An outer sheath22 is placed over the limiter 21 to aid in the insertion of the cannula18 into the incision already created in the patient. The outer sheath 22may be designed to partially surround the limiter 21 so that the usermay still see at least a portion of the limiter 21 when the needle 20 isbeing inserted into the incision. The outer sheath 22 is removed by theuser once the cannula 18 has been inserted into the incision site.

One embodiment of a needle 20 a that may be used as the needle 20 inFIG. 1 is shown in FIGS. 2-4. As shown, the needle 20 a includes asleeve 34 a that is attached to the cannula 18 at a proximal end. Theneedle 20 a also includes a distal end 36 a that is connected to thesleeve 34 a and is constructed and arranged to be inserted into ameniscus or a tissue. The distal end 36 a is substantially straight andincludes a point 38 a for piercing the meniscus or tissue and a slot 40a, which allows for the flexible length 58 of the suture 12 to extendout of the needle 20 a. As shown in the Figures, the distal end 36 a ofthe needle 20 a also includes a cutting surface 37 a that is constructedand arranged to cut excess suture 12, which will be described in greaterdetail below.

As shown in FIGS. 2-4, a cutting sheath 35 a that at least partiallysurrounds the distal end 36 a may also be provided. In the illustratedembodiment, the cutting sheath 35 a completely surrounds thecircumference of the distal end 36 a. In other embodiments, the cuttingsheath 35 a may only partially surround the distal end 36 a. The cuttingsheath 35 a is configured to be slidable relative to the distal end 36 aso that it may be moved longitudinally along the distal end 36 a towardthe point 38 a, and then moved back again toward the sleeve 34 a. Thecutting sheath 35 a may include a tab that extends outward from theneedle 20 a so that the user may manipulate the cutting sheath 35 a viathe tab. As shown, the cutting sheath 35 a includes at least one cuttingsurface 33 a that is constructed and arranged to cut excess suture 12,which will be described in greater detail below.

As shown in FIG. 4, the distal end 36 a is configured to hold the pairof anchors 60, 70 of the suture 12. The needle 20 a may include a dimple39 a located near the point 38 a to assist in seating the anchors 60, 70prior to deployment of the anchors 60, 70 from the needle 20 a, as willbe described in greater detail below. The needle 20 a may bemanufactured from, for example stainless steel, and is sized towithstand insertion through the implant and the meniscus substantiallywithout bending or budding.

Another embodiment of a needle 20 b that may be used as the needle 20 inthe applicator 10 is shown in FIGS. 5-7. As shown, the needle 20 bincludes a sleeve 34 b that is attached to the cannula 18 at a proximalend. The needle 20 b also includes a distal end 36 b that is connectedto the sleeve 34 b and is constructed and arranged to be inserted into ameniscus or a tissue. The distal end 36 b is curved such that it extendsat an angle α relative to the sleeve 34 b. The angle α may be about15-45 degrees, and for example, about 30 degrees. The distal end 36 balso includes a point 38 b for piercing the meniscus or tissue and aslot 40 b, which allows for portions of the suture 12 to extend out ofthe needle 20 b. The distal end 36 b of the needle 20 b also includes atleast one cutting surface 37 b that is constructed and arranged to cutexcess suture 12.

As shown in FIGS. 5-7, a cutting sheath 35 b that at least partiallysurrounds the distal end 36 b may also be provided. In the illustratedembodiment, the cutting sheath 35 b completely surrounds thecircumference of the distal end 36 b. In other embodiments, the cuttingsheath 35 b may only partially surrounds the distal end 36 b. Thecutting sheath 35 b is configured to be slidable relative to the distalend 36 b so that it may be moved longitudinally along the distal end 36b toward the point 38 b, and back again to the sleeve 34 b. The cuttingsheath 35 b may include a tab that extends outward from the needle 20 bso that the user may manipulate the cutting sheath 35 b via the tab. Asshown, the cutting sheath 35 b includes a cutting surface 33 b that isconstructed and arranged to cut excess suture 12.

As shown in FIG. 7, the distal end 36 b is also configured to hold thepair of anchors 60, 70. The needle 20 b may also include a dimple 39 blocated near the point 38 b to assist in seating the anchors 60, 70prior to deployment. Like the needle 20 a of FIGS. 2-4, the needle 20 bmay be manufactured from, for example, stainless steel, and is sized towithstand insertion through the implant and the meniscus substantiallywithout bending or buckling.

An embodiment of the pusher 23 is shown in greater detail in FIG. 8. Therod 24 is hollow and is configured to receive the flexible length 58 ofthe suture 12 that extends away from the needle 20. The knob 26 includesa hole for receiving the rod 24, so that the flexible length 58 of thesuture 12 may extend through the knob 26 as well. A distal portion ofthe rod 24 includes a pair of slots 42 that are configured to allow theflexible length 58 of the suture 12 to be threaded out of the rod 24 viaone slot 42 (the distal slot) and back into the rod 24 via the otherslot 42 (the proximal slot), as represented by an exposed portion 44 ofthe flexible length 58 of the suture 12. This threading of the suture 12properly aligns the exposed portion 44 relative to the rod 24 tofacilitate the cutting of the suture 12, which will be described infurther detail below. As shown in FIG. 7, the rod 24 may be flexible sothat it may be used with the embodiment of the needle 20 b describedabove.

FIGS. 9-11 illustrated an embodiment of an anchor 46 that may be used asthe anchors 60, 70 of the suture 12. As shown, the anchor 46 includes atab 48 that extends upward from a body 50. The body 50 has opposing ends51 that are substantially perpendicular to a longitudinal axis LA of theanchor 46. A hole 52 that is centered on the longitudinal axis LAextends through the body 50 and the tab 48 where the body 50 and tab 48are connected. Otherwise, the body 50 includes a hollowed outhalf-cylinder 53 at portions where the tab 48 is not connected. Theanchor 46 may be made out of any material desired such as, polymer, forexample polyether ether ketone (PEEK), or a bioabsorbable polymer, forexample poly(L-lactide).

Another embodiment of an anchor 54 for use in the suture 12 of thesystem 1 is shown in FIGS. 12-14. As shown, the anchor 54 is a solid rodwith a pair of holes 56 that extend substantially perpendicularlythrough the longitudinal axis of the rod. The holes 56 are sized toreceive a flexible portion of the suture 12. A recessed channel 57 islocated between the holes 56 to seat the flexible length 58 of thesuture 12. Like the anchor 46, the anchor 54 may be made out of anymaterial desired such as, polymer, for example polyether ether ketone(PEEK), or a bioabsorbable polymer, for example poly(L-lactide).

In another embodiment of an anchor that may be used as one or both ofthe anchors 60, 70 of the suture 12, the anchor may include at least onebarb that is formed from or connected to a main body portion of theanchor. The barb may be constructed and arranged to be biased to anorientation in which a free end of the barb extends away from the body,yet is oriented such that the free end is near the body when suitablepressure is applied to the barb. The use of such an anchor with thesystem 1 will be described in greater detail below.

Unless otherwise indicated herein, further discussions of the anchors60, 70 will be for the anchor 46 illustrated in FIGS. 9-11, although itis understood that the anchor 54 of FIGS. 12-14 may be used with slightmodifications to the language used to describe the assembly of thesuture 12. Such modifications would be readily appreciated by one ofskill in the art and are therefore not described herein.

FIGS. 15-23 show the various stages of an embodiment of assembling thesuture 12 of the system 1 of FIG. 1. FIG. 15 shows the flexible length58 of the suture 12 with one anchor 60 threaded thereon. FIG. 16 shows aloop 62 and a knot 64 that closes the loop 62, with the anchor 60 beinglocated within the loop 62. The knot 64 may be a self-locking slideknot. Methods for tying a self-locking slide knot are described in, forexample, “A New Clinch Knot,” Weston, P. V., Obstetrics & Gynecology,Vol. 78, pp. 144-47 (1991); “Physical Properties of Self Locking andConventional Surgical Knots,” Israelsson, L. A., et al., EuropeanJournal of Surgery, Vol. 160, No. 6-7, pp. 323-27 (1994); “Nicky'sKnot—A New Slip Knot for Arthroscopic Surgery,” De Beer, J. F., et al.,Arthroscopy: The Journal of Arthroscopic and Relate Surgery, Vol. 14, No1, pp. 109-110 (1998); “The Giant Knot: A New One-Way Self-LockingSecured Arthroscopic Slip Knot,” Fleega, B. A., et al., Arthroscopy: TheJournal of Arthroscopic and Relate Surgery, Vol. 15, No 4, pp. 451-52(1999); “Arthroscopic Knot Tying Techniques,” Nottage, W. M., et al.,Arthroscopy: The Journal of Arthroscopic and Relate Surgery, Vol. 15, No5, pp. 515-521 (1999); “The SMC Knot—A New Slip Knot With LockingMechanism,” Kim, S., et al., Arthroscopy: The Journal of Arthroscopicand Relate Surgery, Vol. 16, No 5, pp. 563-65 (2000); “Technical Note: A‘New’ Arthroscopic Sliding Knot,” Field, M. H., et al., OrthopedicClinics of North America, Vol. 32, No. 3, pp. 525-26 (2001);“Arthroscopic Knot Tying,” Kim, S., et al., Techniques in Shoulder &Elbow Surgery, Vol. 4, No. 2, pp. 35-43 (2003); “The PC Knot: A Secureand Satisfying Arthroscopic Slip Knot,” Pallia, C. S., Arthroscopy: TheJournal of Arthroscopic and Relate Surgery, Vol. 19, No 5, pp. 558-560(2003); and “The Tuckahoe Knot: A Secure Locking Slip Knot,” Wiley, W.B., et al., Arthroscopy: The Journal of Arthroscopic and Relate Surgery,Vol. 20, No 5, pp. 556-59 (2004), all of which are incorporated hereinby reference in their entireties.

Once the self-locking slide knot 64 has been tied, another anchor 70 isslid onto the flexible length 58 until it is located approximately 7 mmfrom the knot 64, as shown in FIG. 17 (note that the Figures are notnecessarily drawn to scale). This distance is only meant to be anexample and is not intended to be limiting in any way. The flexiblelength 58 of the suture 12 is tied off with one hitch knot 74 on theanchor 70, as shown in FIG. 18.

Next, as shown in FIG. 19, a needle 72 is threaded with the remainder ofthe flexible length 58. The end of the flexible length 58 with theneedle 72 is passed through the center of the suture of the hitch knottwice to hold the hitch knot 74 in place, as shown in FIGS. 20 and 21.As shown in FIG. 22, the excess flexible length 58 is cut, leavingapproximately 2 mm as a tail. Finally, as shown in FIG. 23, the tip ofthe flexible length 58 may be melted to prevent fraying of the suture12. An assembled suture 12 before it is loaded into the applicator 10 isshown in FIG. 26.

FIG. 24 shows a damaged meniscus 80 having a rim 81, and an implant 82positioned adjacent the damaged part of the meniscus 80. The implant 82may be any type of implant 82 suitable for such meniscus repair. Forexample, the implant 82 includes collagen. In an embodiment, the implant82 includes the CMI, a collagen-based meniscus implant. The implant 82illustrated in the Figures has already been cut to the appropriate size.Both ends of the implant 82 may be temporarily stapled or sutured usingconventional means to hold the implant 82 in place while it is beingsecured to the meniscus 80. FIG. 25 shows a pair of staples 84, orsutures, holding the implant 82 in place.

To load the suture 12 into the applicator 10, the cannula 18, with theneedle 20 a attached, is inserted into the body portion 14 of theapplicator 10. In this embodiment, the needle 20 a of FIGS. 2-4 isshown. However, it is understood that the needle 20 b may also be usedin the same way. The illustrated and described embodiments are notintended to be limiting in any way. While holding down the side lever 32with a finger or a thumb, the rod 24 of the pusher 23 is inserted by theuser into the proximal end 15 of the body portion 14 until the end ofthe rod 24 extends past the point 38 a of the needle 20 a with the slots42 facing upward, as shown in FIG. 27.

Next, as shown in FIG. 28, an end 59 of the suture 12 that is oppositethe anchor 70 is threaded though the rod 24 of the pusher 23 at thedistal end 36 a of the needle 20 a. The end 59 of the suture 12 is lacedthrough the distal end of the rod 24, pulled out of the rod 24 at thedistal slot 42, threaded back into the rod 24 at the proximal slot 42,thereby leaving the exposed portion 44 outside of the rod 24. The end 59of the suture 12 may extend several inches outside the pusher 23 beyondthe proximal end 15 of the body portion 14 of the applicator 10 so thatthe user may grasp the suture 12 during the implant attachmentprocedure, which will be described below. Once the suture 12 has beenloaded into the applicator 10, the user then presses the side lever 32and retracts the pusher 23 back into the needle 20 a, as shown in FIG.29, to locate the slots 42 and the exposed portion 44 of the suture 12before the proximal end of the needle slot 40 a, as shown in FIG. 30.The anchor 60 is inserted into the distal end 36 a of the needle 20 a,and is followed by the anchor 70, as shown in FIGS. 30 and 31. The end59 of the flexible length 58 that extends out of the pusher 23 at theproximal end 15 of the body portion 14 of the applicator 10 may bepulled so that the knot 64 is generally located on a side of the anchor60 that is opposite the other anchor 70, as shown in FIG. 31 After theanchors 60, 70 are loaded into the cannula 18, a portion of the flexiblelength 58 may extend outside of the cannula 18 via the slot 40 a of theneedle 20 a, as shown in FIGS. 30 and 31. In this arrangement, thepulling of the trigger 30 causes the anchor 70, the anchor 60, and theknot 64 to be deployed in that order.

Once the system 1 is assembled, the user places the spacer 28 betweenthe knob 26 and the proximal end 15 of the body portion 14 so that theadvancement of the anchor 60 will be limited until the placement of theanchor 70 is complete. The user then inserts the depth penetrationlimiter 21 and the outer sheath 22 over the distal end of the cannula 18so as to cover the needle 20 during insertion of the needle 20 into theincision site. Once the needle 20 has been inserted into the incisionsite, the outer sheath 22 may be removed from the cannula 18. Of course,the use of the spacer 28, the outer sheath 22, and the depth penetrationlimiter 21 should be considered optional. The illustrated embodiment isnot intended to be limiting in any way.

The user may then advance the anchors 60, 70 until the anchor 70 islocated near the point 38 a of the needle 20 a, without extending out ofthe needle 20 a. The dimple 39 a may be used to assist with theplacement of the anchor 70. In embodiments where the dimple 39 a isused, the user should feel a slight resistance to the advancement of theanchor 70, which signals the user to stop advancing the pusher 23. Ofcourse, the use of the dimple 39 a should be considered to be optional.The illustrated embodiment is not intended to be limiting in any way.

While griping the handle 16 and the trigger 30 on the applicator 10, theuser inserts the needle 20 a into a patient at an incision site so thatthe needle 20 a may then be inserted through the implant 82 and throughthe meniscus 80 at a first location 86, for example near the center ofthe implant 82, to a side opposite the insertion site, as shown in FIG.32. The user should be sure that the hitch knot 74 on the anchor 70 haspassed through the meniscus 80, as shown in FIG. 32. In an embodiment,the user then advances the pusher 23 via the trigger 30 until the anchor70 is pushed outside the needle 20 a, as shown in FIG. 33. The usershould be careful to not advance the pusher 23 further to avoid thepremature deployment of the anchor 60. The use of the spacer 28 assistsin preventing the premature deployment of the anchor 60. In addition to,or in lieu of the spacer 23, the dimple 39 a that is located near thepoint 38 a of the needle 20 a may also be used to provide the user withtactile feedback that the anchor 60 has been advanced to its properpre-deployment position.

As shown in FIG. 34, the user then retracts the needle 20 a slowly fromthe meniscus 80 and the implant 82, leaving the anchor 70 behind on theopposite side of the meniscus 80. The anchor 60 will remain inside theneedle 20 a. If the user hasn't already done so, the user next advancesthe anchor 60 until the anchor 60 is located near the point 38 a of theneedle 20 a. Again for embodiments that include the dimple 39 a, thedimple 39 a may be used to guide the user to correctly position theanchor 60.

While gripping the handle 16 and the trigger 30 on the applicator 10,the user inserts the needle 20 a though the implant 82 and through themeniscus 80 at a second location 88, which may be for example near thefirst location 86, until the center of the anchor 60 is outside theopposite side of the meniscus 80, as shown in FIG. 35. If the userhasn't already done so, the user next removes the spacer 28 from the rod24 by grasping the tab 29 and pulling the spacer 28 away from the rod24. The user then advances the pusher 23 until the anchor 60 is pushedoutside the needle 20 a, as shown in FIG. 36. The user then retracts theneedle 20 a, thereby leaving the anchor 60 on the opposite side of themeniscus 80, as shown in FIG. 37.

Having deployed both anchors 60, 70, the user may then advance thepusher 23 via the trigger 30 so that the rod 24 extends approximately 1cm beyond the point 38 a of the needle 20 a, as shown in FIG. 38. Whilegripping the handle 16 and the trigger 30 of the applicator 10, the userthen holds the tip of the rod 24 against the knot 64 and pushes the knot64 to the surface of the implant 82, being careful not to push the knot64 through the implant 82. The user continues to grip the handle 16 andthe trigger 30 while gently pulling on the end 59 of the flexible length58 of the suture 12 at the proximal end 15 of the body portion 14 of theapplicator 10 until slack in the suture 12 is taken up, and the anchors60, 70 sit flat against the meniscus 80, as shown in FIGS. 39 and 40.

With the knot 64 now secured, the user may extend the rod 24 of thepusher 23 out of the needle 20 a approximately 1 cm. The user may thenrotate the pusher 23 up to approximately 180 degrees, or until the slots42 and the exposed portion 44 of the suture 12 are positioned to comeinto contact with the cutting surface 37 a when the pusher 23 is pulledback toward the proximal end 15 of the body portion 14 of the applicator10, as shown in FIG. 41. Holding the end 59 of the flexible length 58that extends out of the proximal end 15, the user may shear the exposedportion 44 of the suture 12 against the cutting surface 37 a by slidingthe pusher 23 longitudinally against the cutting surface 37 a, as shownin FIG. 41, thereby leaving a short tail 67 near the knot 64, as shownin FIG. 43. The pusher 23 may have to be moved back and forth againstthe cutting surface 37 a before the suture 12 is fully cut.

In another embodiment, after the knot 64 is secured, while holding theend 59 of the flexible length 58 that extends out of the proximal end15, the user may shear the exposed portion 44 of the suture 12 againstthe cutting surface 33 a by sliding the cutting sheath 35 a along thedistal end 36 a and toward the point 38 a of the needle 20 a, as shownin FIG. 42, thereby leaving a short tail 67 near the knot 64, as shownin FIG. 43. The cutting sheath 35 a may have to be moved back and forthalong the distal end of the needle 20 a before the suture 12 is fullycut.

The aforementioned system 1 and method provide an all-inside suturefixation to the implant and meniscus, because the needle 20 a of theapplicator 10 has not been removed from the patient's body between thedeployment of the anchor 70, the pushing of the knot 64, and the cuttingof the excess flexible length 58 of the suture 12. This may bebeneficial to the patient because it may reduce the time the applicator10 is in the patient's body, and allows for a single, small entry pointof the needle 20 a, at the incision, into the patient's body.

The user may then repeat the steps shown in FIGS. 32-43 for anyremaining sutures 12 that are needed to complete the fixation of theimplant 82 to the meniscus 80. Generally, it may take three or moresutures 12 to secure the implant 82.

Of course, in alternative embodiments, the user may remove the bodyportion 14 of the applicator 10 and pusher 23 from the cannula 18, andtrim the excess flexible length 58 of the suture 12 with scissors, orsome other cutting device. The illustrated embodiments are not intendedto be limiting in any way.

Also, in alternative embodiments, one or both of the anchors 60, 70 maybe the anchor described above that includes one or more barbs. Thisallows the user to advance the pusher 23 via the trigger 30 only until adistal end of the anchor is located adjacent the point of the needle 20in an orientation in which the barb is no longer engaged by the wall ofthe needle 20. When the anchor is in this position, the wall of theneedle 20 is no longer exerting pressure on the barb, thereby allowingthe barb to be biased outward and away from the body of the anchor. Thebarb may then be used to engage the anchor with the meniscus 80 so thatwhen the user pulls the needle 20 back through the meniscus 80 and theimplant 82, the entirety of the anchor will pull out of the needle 20without further advancement of the pusher 23.

It is also contemplated that the needle 20 may be designed such that thetab 48 on the anchor 46 may be used to engage the anchor 46 with themeniscus 80 before the anchor 46 exits the needle 20. This allows theentirety of the anchor 46 to be pulled out of the needle 20 when theneedle 20 is pulled back through the meniscus 80, rather than pushingthe entirety of the anchor 46 out of the needle 20 with the pusher 23,as described in the embodiments above.

Although the above-described procedure was in the context of attachingan implant to a meniscus with needle penetration of the implant and themeniscus in a substantially horizontal stitch, a substantially similarprocedure may be used for the placement of other types of stitches, suchas vertical and oblique, as would be appreciated by one of skill in theart. The illustrated and described embodiments should not be consideredto be limiting in any way.

In addition, although the above-described procedure was in the contextof attaching an implant to a meniscus, a substantially similar proceduremay be used to repair soft tissue, as would be appreciated by one ofskill in the art. The illustrated and described embodiments should notbe considered to be limiting in any way. For example, to repair a tearin the meniscus 80 with the suture 12, the needle 20 may be insertedthrough the meniscus 80 a first location near the tear. The first anchor70 of the suture 12 may then be delivered to an opposite side of themeniscus 80, and the needle 20 retracted from the meniscus 80, withoutpulling out of the body. The needle may then be inserted through themeniscus 80 at a second location on an opposite side of the tear as thefirst location. The second anchor 60 of the suture 12 may then bedelivered to the opposite side of the meniscus 80. Once the secondanchor 60 is in the proper position, the user may then push the knot 64to a surface of the meniscus 80 to tighten the suture. The excess of theflexible length 58 of the suture 12 may then be cut with any of thecutting methods described above.

In another embodiment, illustrated in FIGS. 44-52C, a system 100 forrepairing a meniscus is provided. The system 100 includes an applicator110 that is constructed and arranged to deploy the suture 12, whichincludes the flexible length 58 and the two anchors 60, 70, as describedabove, to the meniscus. In this embodiment, the applicator 110 includesa body portion 114 that is configured to be grasped by the user. Asshown in FIGS. 44 and 45, the body portion 114 includes a pair ofextensions 116 at a proximal end 115 of the body portion 114. Each ofthe extensions 116 is constructed and arranged to engage a finger of theuser such that the body portion 114 is may be held in between thefingers in a similar way that a syringe is typically held.

As illustrated in FIG. 44, the body portion 114 of the applicator 110receives a cannula 118 that extends from a distal end 113 of the bodyportion 114 in a direction that is away from the proximal end 115. Thecannula 118 may be constructed and arranged like the cannula 18described and illustrated above, and in U.S. Pat. No. 5,928,252, whichis hereby incorporated by reference in its entirety, and may beconnected to the body portion 114 in a similar manner.

The applicator 110 also includes a needle 120 that has a cutting surface121 at a distal end thereof. The needle 120 is connected to a distal endof the cannula 118 so that it is operatively connected to the distal end113 of the body portion 114. Of course, the needle 120 may be consideredto be a part of the cannula 118 itself. The needle 120 may be of thesame design as the needle 20 a discussed above. As such, details of theneedle 120 will not will be described in further detail. Instead,reference should be made to the needle previously described andillustrated.

The applicator 110 also includes a pusher 123. The pusher 123 includes arod 124 (shown in FIG. 46) that extends through a central lumen 112 ofthe body portion 114, a central bore (not shown) of the cannula 118, andis slidingly received by the needle 120. A knob 126 is attached to oneend of the rod 124 and is configured to be grasped by the user so thatthe user may manipulate the rod 124, as described in further detailbelow. As shown in FIG. 46, the rod 124 includes proximal end 125 and adistal end 127, which has a smaller diameter than the diameter ofproximal end 125, as illustrated. The distal end 127 is configured toinclude a pair of slots 142 that are similar to the slots 42 discussedabove. A central bore 122 extends through the rod 124 and the knob 126so that the flexible length 58 of the suture 12 may be threaded throughthe slots 142, through the rod 124, and through the knob 126, as shownin FIG. 46.

As illustrated in FIG. 46, the pusher 123 includes a first projection128 that projects from the rod 124 and defines a first stop surface 129on one side thereof. The first projection 128 may be configured as asquare or rectangular tab, or may be in the shape of a cylinder. Theillustrated embodiment is not intended to be limiting in any way. Theknob 126 of the pusher 123 includes a stopper portion 130 that isconnected to the rod 124 and defines a second stop surface 131. Thepusher 123 also includes a second projection 132 that projects from therod 124 and defines a third stop surface 133 on one side thereof. Thesecond projection 130 is axially spaced from the first projection 128and is axially located between the first projection 128 and the distalend 127 of the rod 124.

As shown in FIG. 47, the second projection 130 is also radially spacedfrom the first projection 128. The radially spacing is defined by angleβ, and in the illustrated embodiment, the angle β is about 90 degrees.It is contemplated that the angle β may be in the range of about 10degrees to about 370 degrees, as will be appreciated in the discussionbelow. The illustrated embodiment is not intended to be limiting in anyway.

As shown in FIG. 45, the body portion 114 defines an outer surface 134at its proximal end that is configured to engage the stop surfaces 129,131, 133 described above as the pusher 123 is moved to differentpositions relative to the body portion 114 and needle 120. The bodyportion 114 also includes an opening 136, shown in the Figures to beshaped as a keyhole, that is axially connected to the central lumen 112and is constructed and arranged to receive the first projection 128 andthe second projection 130 of the pusher 123, as discussed in furtherdetail below. The arrangement of the opening 136 in the proximal end 115of the body portion 114 is such that the pusher 123 should be in theproper orientation relative to the body portion 114 in order for thepusher 123 to move toward the needle 120 in an axial direction. Once thefirst projection 128 or the second projection 130 has passed through theopening, the respective projection 128, 130 is then located within thecentral lumen 112 of the body portion 114. The central lumen 112 issized to allow the projections 128, 130 to rotate with the rod 124 abouta central axis. However, when one of the projections 128, 130 ispositioned within the opening 136, the rod 124 will be prevented fromrotating.

FIGS. 48A-53C illustrate portions of the system 100 during differentstages of repairing a meniscus or other soft tissue. As shown in FIGS.48A-C, the pusher 123 is disposed in a first orientation and first axialposition relative to the body portion 114 and the needle 120. In thisorientation and position, the third stop surface 133 is engaged with theouter surface 134 of the body portion 114 such that pressure applied tothe knob 126 toward the body portion 114 will not cause the pusher 123to move in an axial direction. This allows the first anchor 70 to staywithin the needle 120, as shown in FIG. 48C, even if pressure is appliedto the pusher 123 via the knob 126. This may allow the user to applypressure to the applicator 110 via the knob 126 as the needle 120 isinitially inserted through the implant 82 and meniscus 80, as describedabove. For example, the user may hold the body portion 114 and engagethe extensions 116 with two fingers, while applying pressure to the knob126 with a thumb, like a syringe.

Once the needle 120 is in the proper location for the discharge of thefirst anchor 70, the user may rotate the pusher 123, via the knob 126,to a second orientation, which is 90 degrees from the first orientation,as shown in FIGS. 49A-C. This orientation aligns the second projection132 of the pusher 123 with the opening 136 of the body portion 114, asshown in FIG. 49B. Because the pusher 123 has not yet been movedaxially, the first anchor 70 is still located in the needle 120, asshown in FIG. 49C.

The user may then apply pressure to the pusher 123 in an axial directionvia the knob 126 until the first surface 129 of the first projection 128engages the outer surface 134 of the body portion 114, as shown in FIG.50A. At this position, the second projection 132 has passed all the waythrough the opening 136 of the body portion 114 such that is in thecentral lumen 112. As shown in FIG. 50C, the first anchor 70 has beendischarged by the pusher 123 out of the needle 120. Other aspects of thedischarge of the anchor 70 are discussed above and shown in FIG. 33.

As discussed above and shown in FIGS. 34 and 35 with reference to theneedle 20 a, the user may then pull the needle 120 in a similar mannerso that it clears the meniscus 80 and the implant 82, and then insertthe needle through the implant 82 and the meniscus 80 at a secondlocation. Once the distal end of the needle 120 is in the location wherethe second anchor 60 should be discharged, the user may then rotate thepusher 123 to a third orientation, as shown in FIGS. 51A-C, which is 90degrees from the second orientation, and 180 degrees from the firstorientation. At this orientation, the first protrusion 128 is alignedwith the opening 136, and the second anchor 60 is still located withinthe needle 120.

The user may then apply pressure to the pusher 123 via the knob 123until the second stop surface 131 of the stopper 130 engages the outersurface 134 of the body portion 114, as shown in FIGS. 52A-B. Asillustrated, in this position, the first projection 128 has passed allof the way through the opening 136 and is in the central lumen 112 ofthe body portion 114. As shown in FIG. 52C, the second anchor 60 hasbeen discharged from the needle 120 by the pusher 123. Other aspects ofthe discharge of the second anchor 60 are discussed above and shown inFIG. 36. As discussed above and shown in FIGS. 37-40, the knot 64 of thesuture 12 may then be pushed against the implant 82, although in thisembodiment, the distal end 127 of the rod 124 of the pusher 123 is usedto push the knot 64 rather than the rod 24 shown in FIGS. 37-40. Oncethe knot 64 has been tightened and any slack is taken out of theflexible length 58 of the suture 12, the pusher 123 may be rotated outof the third orientation, as shown in FIGS. 52A-C so as to shear theflexible length 58 of the suture 12 against the cutting surface 121 ofthe needle 120. Once the flexible length 58 has been cut, the applicator110 may be pulled out of the body. The applicator 110 may then bedisposed of, or, if desired, may be cleaned, sterilized, and used again.

In another embodiment, as illustrated in FIGS. 54-59, there is provideda system 305 which generally comprises an anchor assembly 310 for use insecuring together two or more objects within the body of a patient(e.g., as in re-approximating soft tissue portions or securing animplant to soft tissue), and an inserter 315 for deploying anchorassembly 310 within the body of a patient. Note that in FIGS. 54-59,portions of anchor assembly 310 (i.e., the terminus knot and the slipknot, which will be hereinafter discussed) are shown in schematic formfor clarity of illustration.

Anchor assembly 310 is shown in further detail in FIGS. 60 and 61.Anchor assembly 310 generally comprises a pair of anchors 320 (i.e., adistal anchor 320A and a proximal anchor 320B) and a suture 325 foradjustably connecting together the pair of anchors 320 (i.e., distalanchor 320A and proximal anchor 320B). Note that in FIG. 60, portions ofanchor assembly 310 (i.e., the terminus knot and the slip knot, whichwill be hereinafter discussed) are shown in schematic form for clarityof illustration, and in FIG. 61, the terminus knot and the slip knot(which will be hereinafter discussed) are shown in one exemplaryembodiment.

The pair of anchors 320 (i.e., distal anchor 320A and proximal anchor320B) are illustrated as being identical to one another and are shown ingreater detail in FIGS. 62-67. More particularly, anchors 320 comprisegenerally cylindrical bodies 330 having upraised portions 335. Thedistal ends of anchors 320 comprise a rounded leading edge 337, andgenerally cylindrical bodies 330 may be beveled or chamfered at 340. Theproximal ends of anchors 320 comprise a rounded trailing edge 342, andgenerally cylindrical bodies 330 may be beveled or chamfered at 345.Rounded edges 337, 342 help facilitate smooth passage of anchors 320along the shaft of inserter 315 and through soft tissue, and minimizetrauma to the tissue, as will hereinafter be discussed. Bevels 340, 345may facilitate passage of anchors 320 along the shaft 370 of inserter315, as will hereinafter be discussed.

A pair of bores 350 (i.e., a distal bore 350A and a proximal bore 350B)extend through generally cylindrical bodies 330 and upraised portions335 of anchors 320. Bores 350 are sized to slidably receive suture 325therethrough, as will hereinafter be discussed. As illustrated in FIG.67, A slot 355 connects the lower ends of bores 350 (i.e., distal bore350A and proximal bore 350B) to one another. Slot 355 is sized so thatwhen suture 325 is received in slot 355, suture 325 does not extendbeyond the outer perimeter of generally cylindrical bodies 330. As aresult, when anchors 320 are disposed within the lumen of the shaft ofinserter 315 (see below), suture 325 will not cause any verticaldisplacement of anchors 320 within the lumen of the shaft.

As seen in FIGS. 61 and 68-70, suture 325 is attached to anchors 320 bypassing suture 325 down distal bore 350A of distal anchor 320A,proximally along slot 355 in distal anchor 320A, up proximal bore 350Bof distal anchor 320A, down distal bore 350A of proximal anchor 320B,proximally along slot 355 in proximal anchor 320B, up proximal bore 350of proximal anchor 320B and then proximally along inserter 315.

Note that by providing anchors 320 with upraised portions 335, and byrouting suture 325 vertically through anchors 320 so that the suturepasses through both cylindrical bodies 330 and upraised portions 335,anchors 320 have increased material adjacent to the suture so as toprovide greater strength to the construct. Further, such a suturerouting also separates the suture from the edges of slot 405, asillustrated in FIG. 59, which may minimize the risk of abrasion of thesuture 325 by contact on the edges of slot 405. However, the upraisedportion 335 is not so tall as to extend beyond slot 405, and thus theshape of anchor 320 provides for high strength while still maintaining alow profile to minimize trauma to the soft tissue and/or implant duringimplantation.

The distal end of suture 325 is secured to distal anchor 320A. Moreparticularly, and looking now at FIGS. 61 and 68-70, in one embodimentof the present invention, the distal end of suture 325 comprises aterminus knot 360 which is formed in the length of suture enteringdistal bore 350A of distal anchor 320A and the length of suture exitingproximal bore 350B of distal anchor 320A. Forming terminus knot 360 inthis manner may provide a secure knot in the suture while alsomaintaining a low profile, particularly while the anchors are positionedwithin shaft 370. Such a low profile knot may provide improved tactilefeedback for the surgeon during implantation as less force will berequired to pass the knot through the tissue and/or implant. It shouldbe appreciated that terminus knot 360 may be replaced/omitted bybraiding, fusing or gluing the distal end of suture 325 to distal anchor320A so as to secure the distal end of suture 325 to distal anchor 320A,and/or by forming the suture integral with distal anchor 320A.

Still looking now at FIGS. 61 and 68-70, a slip knot 365 is formed insuture 325 in the length of suture entering distal bore 350A of proximalanchor 320B and the length of suture exiting proximal bore 350B ofproximal anchor 320B. Slip knot 365 is formed such that when anchors320A, 320B have been appropriately deployed in the body of a patient,pulling on the proximal end of suture 325 locks the slip knot, wherebyto set the expanse of suture extending between distal anchor 320A andproximal anchor 320B (and hence secure together two or more objectswithin the body of a patient, for example, re-approximating two portionsof tissue or securing an implant to remaining tissue). In one embodimentof the invention, slip knot 365 may be a so-called one twist half hitch(OTHH) knot. Forming slip knot 365 in this manner may provide a secureknot in the suture. It should also be appreciated that “mirror” imagesof the terminus knot 360, and/or the slip knot 365, and/or combinationsthereof may also be used. One such alternative slip knot is illustratedin FIGS. 68A-70A, where slip knot 365′ is a mirror image of slip knot365 (though all other features described as to FIGS. 68-70 apply equallyto the same features illustrated in FIGS. 68A-70A).

Thus it will be seen that anchor assembly 310 comprises a distal anchor320A, a proximal anchor 320B, and a suture 325 which connects togetherdistal anchor 320A and proximal anchor 320B, with a terminus knot beingformed at distal anchor 320A and a slip knot 365 (or 365′) being formedbetween the anchors 320A, 320B.

Looking next at FIGS. 54-59 and 68-75, inserter 315 generally comprisesa shaft 370, a handle 375 and a pushrod assembly 380 (see FIGS. 56, 58,69 and 72). Inserter 315 may also include a sheath 383.

More particularly, shaft 370 generally comprises a hollow tube having adistal end 385 (FIG. 54), a proximal end 390 and a lumen 395 (FIG. 58)extending therebetween. Distal end 385 of shaft 370 terminates in asharp point 400. A slot 405 (FIG. 68) is formed in distal end 385 ofshaft 370 and terminates in a proximal shoulder 410.

Shaft 370 is sized to slidably receive anchors 320 therein. Moreparticularly, and as seen in FIGS. 58, 59 and 69, generally cylindricalbodies 330 of anchors 320 are slidably received within lumen 395 ofshaft 370, with upraised portions 335 of anchors 320 being slidablyreceived in slot 405 of shaft 370. Note that the disposition of upraisedportions 335 of anchors 320 in slot 405 provides anchors 320 with aknown disposition relative to shaft 370 and prevents anchors 320 fromrotating relative to shaft 370 (and the remainder of inserter 315) whenanchors 320 are disposed in shaft 370. Note also that, as seen in FIG.59, upraised portions 335 of anchors 320 do not extend radially beyondthe perimeter of shaft 370 (i.e., the outermost portions of anchors 320are contained within an axial projection of the cross-section of shaft370), so that upraised portions 335 of anchors 320 do not engage tissueas shaft 370 of inserter 315 is advanced through tissue. A dimple 415(FIG. 69) may be formed in lumen 395 just proximal to sharp point 400.Dimple 415 provides nominal resistance to the passage of anchors 320along lumen 395, such that anchors 320 cannot accidentally fall out ofthe distal end of shaft 370 and/or be accidentally forced out of thedistal end of shaft 370 when inserter 315 is repositioned; at the sametime, however, anchors 320 can be driven past dimple 415 and out of thedistal end of shaft 370 with the force generated by pushrod assembly380, as will hereinafter be discussed. It should be appreciated thatdimple 415 also provides audible and/or tactile feedback to the surgeonwhich indicates when an anchor 320 is driven past dimple 415 (and outthe distal end of shaft 370). Note that bevels 340 at the distal ends ofanchors 320 facilitate passage of anchors 320 past dimple 415, andfurther may help to reduce potential trauma to the anchors themselvesduring passage past the dimple. Shaft 370 may be straight or curved, asdesired.

Note that, inasmuch as shaft 370 is fixed to handle 375 and inasmuch asanchors 320 are fixed against rotation relative to shaft 370 (i.e., byvirtue of upraised portions 335 of anchors 320 being disposed in slot405 of shaft 370), the user will always know the rotational dispositionof anchors 320, even when the distal end of shaft 370 is disposed at aremote location within the body, from the rotational disposition ofhandle 475.

Still looking now at FIGS. 54-59 and 68-75, handle 375 comprises a body420 (FIG. 72) having a bore 425, a first grip 430, a second grip 435 anda third grip 440. Body 405 comprises a slot 445 (FIG. 75) having a firstportion 450, a second portion 455 and a third portion 460. A firstshoulder 465 is formed at the distal end of first portion 450 andseparates first portion 450 from second portion 455, and a secondshoulder 470 is formed at the distal end of second portion 455 andseparates second portion 455 from third portion 460. The first shoulder465 may also include a proximal projection 466 such that, due to thebias of spring 484, a button actuator 485 (and thus pusher 480, bothdiscussed below)) would be trapped against first shoulder 465. Thus,such a position may be suitable for transport and packaging of inserter315, as well as a beneficial pre-operative and starting position sincethe actuator and pusher can only be actuated by interaction of thesurgeon or other user (e.g., by a proximal force on the actuator 485 orend cap 483 and proximal extension 482, as discussed below). Similarly,the second shoulder 470 may include a proximal ramp 471 which, similarto the proximal projection 466, may assist in seating the actuator 485against the second shoulder 470 until the surgeon is ready to navigateto the third portion 460. The ramp 471 may be less severe of a shape ascompared to projection 466, however, since the force from the spring isless, if not nonexistent, and there is less of a need to protect againstmovement of the actuator 485 due to this position occurring duringmid-surgery, rather than during packaging and shipping. Instead, ramp471 may be useful to provide a tactile response to the surgeon as thesurgeon navigates slot 445 and reaches the third portion 460.

Pushrod assembly 380 generally comprises a cylinder 475 (FIG. 72) whichis sized to be slidably received in bore 425 of body 420 of handle 375,a pusher 480 (FIGS. 56, 58, 69 and 72) which is secured to the distalend of cylinder 475 and is sized to be slidably received in lumen 395 ofshaft 370, and an extension 482 (FIG. 72) which is secured to theproximal end of cylinder 475 and is sized to extend proximally out ofbody 420 of handle 375.

Pusher 480 may be formed of any material desired. For example, pusher480 may be formed of superelastic Nitinol so that pusher 480 may both benaturally lubricious for ease of passing through shaft 370 and flex asit moves through a curved portion of shaft 370. If desired, pusher 480may have a narrowed width at one or more portions along its length so asto further enhance flexibility. By way of example but not limitation,pusher 480 may comprise a distal component 480A (FIG. 58) formed out ofa relatively thin Nitinol rod and a proximal component 480B formed outof a thicker Nitinol rod or a thicker, less flexible material (e.g.,stainless steel). Pusher 480 may be secured to cylinder 475 by securingpusher 480 to another member (e.g., a connector 481, FIG. 72) which isitself secured to cylinder 475. Such a construction can be advantageouswhere the proximal end of pusher 480 is relatively thin (i.e., relativeto cylinder 475) and made out of metal, and cylinder 475 is relativelywide (i.e., relative to the proximal end of pusher 480) and made out ofplastic, since connector 481 can be of intermediate width (which makesit easier to secure to cylinder 475) and made out of metal, so thatpusher 480 can be connected to connector 481 by crimping (e.g., bygrinding a circumferential groove into the proximal end of pusher 480,and then crimping connector 481 onto the circumferential groove inpusher 480). In one example, the pusher 480 may have a “D”-shapedcross-section (not shown), which provides a flat surface on one side.This shape may provide for even further improved action of the pusherwithin shaft 370, particularly through any bend along the length of theshaft which could otherwise cause the pusher to crimp. The connectionbetween pusher and connector 481 may also thus be “D”-shaped, which mayprovide an improved connection between the elements and inhibit rotationof the pusher relative to cylinder 475.

Extension 482 (FIG. 72) terminates in an end cap 483. A spring 484 isdisposed within bore 425 of body 420, as illustrated the spring may bepositioned coaxially over extension 482, and biases cylinder 475, andhence pusher 480, distally. A button actuator 485 is secured to cylinder475 of pushrod assembly 380 and extends through slot 445 in body 420. Ifdesired, button actuator 485 may be contoured (e.g., “cupped”) and/ortextured so as to facilitate engagement by the finger of a user duringuse (e.g., such as when the user is wearing a wet glove, etc.). Buttonactuator 485 allows the user to move cylinder 475 within body 420 (andhence pusher 480 within shaft 370) as will hereinafter be discussed.

More particularly, the thumb (or another finger) of a user can be used(in conjunction with spring 484) to step button actuator 485 through aseries of motions within slot 445 in body 420, whereby to step pusher480 through a series of motions within shaft 370 so as to providecontrolled deployment of anchors 320 from the distal end of shaft 370.More particularly, by moving button actuator 485 from first portion 450of slot 445 into (and along) second portion 455 of slot 445, and thenmoving button actuator 485 into (and along) third portion 460 of slot445, pusher 480 will be stepped through a corresponding series ofmotions with shaft 370 so as to provide controlled deployment of anchors320 from the distal end of shaft 370, as will hereinafter be discussed.Likewise, instead of actuator 485, extension 482 and end cap 483 mayinstead be engaged by a user's hand to step pusher 480 through theseries of motions to provide controlled deployment of anchors 320. Whilespring 484 may not have sufficient force to actually perform thedeployment of anchors 320, the spring biases actuator 485, and thuspusher 480, in a distal direction such that the spring force is in thesame direction as the deployment actions of the user. As such, the userdoes not need to apply additional force during deployment of the anchors320 to overcome the spring force (except when moving the actuator 485away from engagement with the first and second shoulders 465, 470).

Further, sheath 383 may be disposed over at least a portion of shaft370. Sheath 383 comprises a distal end 490 (FIG. 54), a proximal end 495and a lumen 500 extending therebetween. The lumen has a diametersufficient for passage of shaft 370 therethrough, and in instanceswhere, as illustrated, the shaft 370 includes a bend along its length,the lumen may have a diameter sufficient to allow passage of such anonlinear shaft 370 therethrough. Sheath 383 may also have a length thatis somewhat shorter than the length of shaft 370. Further, the sheathmay be cut even shorter, if desired, by trimming a desired length of thedistal portion of the sheath (see FIG. 76, cutting lines 387). In use,as discussed below, if the user determines preoperatively that a longerlength of shaft 370 should be available for passage through the tissueor implant, the user can remove the sheath from the shaft 370 and trimthe sheath at cutting lines 387, and then re-sheath the shaft 370 andcontinue with the procedure. The user may make this determination priorto use of the inserter 315 or by positioning the distal end of inserter315 through the tissue or implant and determining whether the sheathshould be shorter to provide for added length of shaft 370 extendingdistally from the sheath. Proximal end 495 of sheath 383 is releasablymounted to handle 375 (e.g., by fitting sheath 383 over an extension 501formed on handle 375, such as by a press-fit engagement) such that thedistal end of shaft 370 normally protrudes from the distal end of sheath383. Sheath 383 may be selectively detached from handle 375 (e.g.,dismounted from extension 501 of handle 375) and moved distally in orderto temporarily cover the distal end of shaft 370 (e.g., while the distalend of system 305 is being advanced to a remote site within the body).Sheath 383 can then be returned proximally and re-mounted on extension501 of handle 375, whereby to limit the depth that shaft 370 canpenetrate tissue (i.e., before the distal end of sheath 383 contacts thetissue and prevents further distal movement of shaft 370). In one formof the invention, the distance between distal end 490 of sheath 383 andsharp point 400 of shaft 370 is 18 mm when sheath 383 is mounted onextension 501 of handle 375.

In one embodiment of the invention, when anchor assembly 310 is mountedin the distal end of shaft 370, the free end of suture 325 extends outthrough slot 405 in shaft 370, enters lumen 500 of sheath 383, extendsproximally through sheath 383, and out the proximal end 495 of sheath383 (e.g., as illustrated in FIGS. 54-56). When sheath 383 is releasablymounted on extension 501 of handle 375, the proximal end of suture 325may be releasably “pinched” between proximal end 495 of sheath 383 andhandle 375, whereby to releasably hold the free end of suture 325 toinserter 315.

In use, in one embodiment, system 305 is initially in the state wherebutton actuator 485 is disposed in first portion 450 of slot 445, withspring 484 urging cylinder 475 of pushrod assembly 380 distally towardsfirst shoulder 465, and with first shoulder 465 preventing buttonactuator 485 from moving out of first portion 450 of slot 445. Anchors320 of anchor assembly 310 are disposed in the distal end of shaft 370,just proximal to dimple 415. In this state, the distal end of pusher 480is proximal to, or just engaging, the proximal end of proximal anchor320B, and may not apply significant distally-directed force to proximalanchor 320B. Sheath 383 is disposed over shaft 370, with the proximalend of sheath 383 releasably secured to extension 501 of handle 375.With sheath 383 in this position, suture 325 extends proximally throughlumen 500 of sheath 383 and, upon exiting the proximal end 495, can bepinched between the proximal end 495 of sheath 383 and handle 375.

When anchors 320 are to be deployed in the body, sheath 383 can beadvanced distally so as to cover the distal tip of shaft 375 (e.g., inorder to prevent shaft 370 from getting caught on the tissue or causingdamage to tissue or to limit the chance that portions of suture 325extending through slot 405, as in FIGS. 57 and 58, could snag) whileinserter 315 is advanced to an internal surgical site. If desired,inserter 315 may be advanced to an internal surgical site through asurgical cannula (e.g., a plastic arthroscopic cannula). Note that asthe distal end of inserter 315 is advanced to the internal surgicalsite, with sheath 383 positioned distally and over sharp point 400 ofshaft 370, it protects the surgical cannula and intervening tissue fromthe sharp point 400.

Once the distal end of inserter 315 has reached the internal surgicalsite, sheath 383, if positioned distally during insertion of inserter315, is retracted proximally, e.g., so as to be re-seated on extension501 of handle 375 (at this point, sheath 383 may or may not capturesuture 325 to the proximal end of handle 375). Then inserter 315 ismaneuvered such that the distal end of shaft 370 is passed through anobject (e.g., tissue) at a first location, with the distal end of sheath383 limiting the extent of distal advancement as the distal end ofsheath 383 engages the object. Then button actuator 485 is advanced fromfirst portion 450 of slot 445 into second portion 455 of slot 445, i.e.,by pulling proximally on button actuator 485 (or end cap 483) againstthe power of spring 484 so as to cause button actuator 485 to clearfirst shoulder 465 and projection 466, rotating button actuator 485 (orend cap 483) circumferentially, and then advancing button actuator 485(using either actuator 485 or end cap 483) distally along second portion455 of slot 445 until button actuator 485 engages second shoulder 470.The user can either release the actuator 485 (or proximal extension 482)to allow the spring to force the actuator 485 distally through thesecond portion 455, or the user can control the movement of the actuatorthrough the second portion 455. Either way, this action advancescylinder 475 distally such that pusher 480 contacts proximal anchor 320Band/or pushes proximal anchor 320B (and hence distal anchor 320A)distally, whereby additional distal force by the user deploys distalanchor 320A out of the distal end of shaft 360. Note that secondshoulder 470 prevents button actuator 485 from advancing so far as tocause deployment of proximal anchor 320B from shaft 360.

At this point a slight proximal force may be applied to suture 325,whereby to snug proximal anchor 320A into position relative to theobject (e.g., tissue) and to remove undesired slack from suture 375.

Shaft 370 is then withdrawn from the object (e.g., tissue), i.e., bymoving inserter 315 proximally, inserter 315 is moved laterally (i.e.,to any location other than the first location) to a second locationrelative to the object, and then the distal end of shaft 370 is advancedthrough the object (e.g., tissue) at the second location. Buttonactuator 485 is then advanced from second portion 455 of slot 445 intothird portion 460 of slot 445, i.e., by pulling proximally on buttonactuator 485 (or end cap 483) so as to clear second shoulder 470 andramp 471 (a distal spring force may or may not be present from spring484 during this step), rotating button actuator 485 (or end cap 483)circumferentially, and then advancing button actuator 485 distally alongthird portion 460 of slot 445, until button actuator 485 engages thedistal end of third portion 460 of slot 445. This action advancescylinder 475 distally, such that pusher 480 contacts proximal anchor320B and deploys proximal anchor 320B out of the distal end of shaft370. The third portion 460 dead-ends which may prevent the pusher fromextending distally from shaft and damaging surrounding tissue.

Shaft 370 is then withdrawn from the object (e.g., tissue), i.e., bymoving inserter 315 proximally, and then the proximal end of suture 325is pulled proximally whereby to snug distal anchor 320B into positionrelative to the object (e.g., tissue) and to cinch slip knot 365,whereby to set the expanse of suture extending between distal anchor320A and proximal anchor 320B. In this way anchors 320A, 320B can beused to hold two or more objects together within the body of a patient,such as in re-approximating soft tissue portions or securing an implantto soft tissue.

Significantly, with the present invention, the user has the option ofholding (and actuating) inserter 315 with a variety of grips. By way ofexample but not limitation, and looking now at FIG. 76, the user mayhold inserter 315 so that the index finger engages first grip 430, thethumb engages second grip 435 or button actuator 485, and/or the middle,ring and little finger wrap around the barrel of body 420 of handle 375.This manner of holding inserter 315 is somewhat analogous to the mannerin which a user might hold a steak knife or a pool cue. Alternatively,in another example and looking now at FIG. 77, the surgeon may holdinserter 315 so that the middle and ring fingers engage third grip 440and the thumb engages end cap 483. This manner of holding inserter 315is somewhat analogous to the manner in which a user might hold asyringe.

In still another alternative example, as illustrated in FIGS. 78-82, thesurgeon may hold the inserter 315 like a ballpoint pen. In thisexemplary use (based on the discussion herein), the surgeon may engagethe extension 482 and/or the end cap 483 between thumb and index finger,with the other three fingers wrapped around handle 375 such that thirdgrip 440 is positioned between two fingers (such as pinkie and ringfingers, as illustrated in FIGS. 78, 79 and 81). This grip allows forboth rotation of extension 482, and thus actuator 485, and, by pressingon the proximal surface of the end cap 483 with the thumb (FIG. 82),axial movement of the extension 482, and thus pusher to deploy theanchors. As illustrated in FIG. 80, the extension 482 may be releasedwhile the actuator 485 is positioned within the second portion 455, suchthat spring 484 automatically moves actuator 485, and thus pusher 480distally. However, spring 484 may not have sufficient force to eject thedistal anchor from shaft 370. Such a spring force may decrease the riskof accidental deployment of the distal anchor, such that depression ofthe thumb on end cap 483 is required for actual deployment.

It should also be appreciated that, inasmuch as shaft 370 is fixed tohandle 375 and inasmuch as anchors 320 are fixed against rotationrelative to shaft 370 (i.e., by virtue of upraised portions 335 ofanchors 320 being disposed in slot 405 of shaft 370), the position offirst grip 430 and second grip 435 of handle 375 indicate the rotationaldisposition of anchors 320 within shaft 370 even when the distal end ofshaft 370 is disposed at a remote location within the body. And itshould also be appreciated that where shaft 370 is curved, the positionof first grip 430 and second grip 435 of handle 375 also indicate theorientation of the curvature of shaft 370.

In another embodiment, the present invention includes a method ofpackaging the inserter 315 including positioning the actuator 485against the first stop 465 to prevent movement of the actuator 485relative to the handle 375, optionally sterilizing the inserter 315and/or packaging, and packaging the inserter 315 in at least one layerof packaging. The inserter 315 may also include the anchor assembly 310positioned within the shaft 370 and ready for use. The packaging mayalso include an instructions for use or surgical technique documentdetailing at least one surgical method for which inserter 315 may beused.

It will be appreciated that certain changes may be made to novel system305 without departing from the scope of the present invention. By way ofexample but not limitation, the configuration of anchor assembly 310 maybe modified, e.g., the configuration and/or number of anchors 320 may bemodified, terminus knot 360 may comprise a knot different than thatdisclosed, slip knot 365 may comprise a slip knot different than thatdisclosed above, etc. By way of further example but not limitation, theconfiguration of inserter 315 may be modified from that disclosed.

The foregoing disclosure of embodiments of the present invention hasbeen presented for purposes of illustration and description. It is notintended to be exhaustive or to limit the invention to the precise formsdisclosed. Many variations and modifications of the embodimentsdescribed herein will be apparent to one of ordinary skill in the art inlight of the above disclosure. The scope of the invention is to bedefined only by the claims appended hereto, and by their equivalents.

Further, in describing representative embodiments of the presentinvention, the specification may have presented the method and/orprocess of the present invention as a particular sequence of steps.However, to the extent that the method or process does not rely on theparticular order of steps set forth herein, the method or process shouldnot be limited to the particular sequence of steps described. Forexample, any number of sutures may be prepared ahead of time. Inaddition, the advancement of the anchors within the cannula may occurbefore or after needle insertion. In addition, the delivery of thesecond anchor may not require that the needle be fully withdrawn; forexample when two anchors are to be delivered through a single insertionsite. As one of ordinary skill in the art would appreciate, othersequences of steps may be possible. Therefore, the particular order ofthe steps set forth herein should not be construed as limitations on theclaims. In addition, the claims directed to the method and/or process ofthe present invention should not be limited to the performance of theirsteps in the order written, and one skilled in the art can readilyappreciate that the sequences may be varied and still remain within thespirit and scope of the present invention.

It should be understood that many additional changes in the details,materials, steps and arrangements of parts, which have been hereindescribed and illustrated in order to explain the nature of the presentinvention, may be made by those skilled in the art while still remainingwithin the principles and scope of the invention.

1. A system for repairing a meniscus comprising: a suture assemblyincluding a first anchor, a second anchor, and a length of sutureconnecting the first anchor and the second anchor, the suture includinga slide knot along its length between the first anchor and the secondanchor; and an inserter, comprising: a needle having a longitudinalextending bore and an open distal end, the bore being configured toreceive the first anchor and the second anchor; a housing operativelyconnected to a proximal end of the needle, the housing having a lumenand a slot, the slot including a first portion, a second portion, afirst shoulder and a second shoulder; and a pusher configured to rotateand slide within the lumen of the housing and the longitudinal extendingbore of the needle, the pusher having an extension extending through theslot and configured to be maneuverable through the first portion andsecond portion and engageable with the first shoulder and secondshoulder.
 2. The system according to claim 1, wherein the extension ofthe pusher is adapted to be engaged by a user.
 3. The system accordingto claim 1, wherein the pusher further comprises a proximal portionextending from the lumen at a proximal end of the housing, the proximalportion being adapted to be engaged by a user.
 4. The system accordingto claim 3, wherein engagement by the user of either of the proximalportion or the extension of the pusher allows the extension to bemaneuverable through the first portion and second portion and engageablewith the first shoulder and second shoulder.
 5. The system according toclaim 1, further comprising a spring engaging the housing and thepusher, the spring biasing the pusher in a distal direction relative tothe housing.
 6. The system according to claim 5, wherein the spring isadapted to bias the extension against the first shoulder.
 7. The systemaccording to claim 1, wherein the housing further comprises a thirdportion, wherein the extension is configured to be maneuverable throughthe third portion.
 8. The system according to claim 7, wherein, with theextension of the pusher in one of the first, second or third portions ofthe slot, the first and second anchors are positioned within the bore ofthe needle, wherein, with the extension in another of the first, secondor third portions of the slot, the pusher is adapted to expel the firstanchor from the open distal end of the bore while the second anchorremains positioned within the bore of the needle, and wherein, with theextension in the other of the first, second or third portions of theslot, and with the first anchor expelled from the open distal end, thepusher is adapted to expel the second anchor from the open distal end ofthe bore.
 9. The system according to claim 7, wherein, with theextension of the pusher in the first portion of the slot and engagedwith the first shoulder, the first and second anchors are positionedwithin the bore of the needle, wherein, as the extension maneuvers fromthe first portion to the second portion of the slot and towards or tothe second shoulder, the pusher expels the first anchor from the opendistal end of the bore while the second anchor remains positioned withinthe bore of the needle, and wherein, as the extension maneuvers from thesecond portion to the third portion of the slot and distally through thethird portion, the pusher expels the second anchor from the open distalend of the bore.
 10. The system according to claim 9, further comprisinga sheath releasably secured to the housing and having a lumen, theneedle being positionable within the lumen.
 11. The system according toclaim 10, wherein the needle includes a bend along a portion of itslength and the sheath is linear along its length, and the lumen of thesheath having a diameter sufficient to pass the bend of the needletherethrough.
 12. The system according to claim 10, wherein a proximalportion of the sheath engages the housing by a press-fit engagement. 13.An instrument for repairing a meniscus comprising: a needle having alongitudinal extending bore and an open distal end; a housingoperatively connected to a proximal end of the needle, the housinghaving a lumen, a slot including a first portion, a second portion, afirst shoulder and a second shoulder, and a first grip and a secondgrip; and a pusher configured to rotate and slide within the lumen ofthe housing and the longitudinal extending bore of the needle, thepusher having an extension extending through the slot and configured tobe maneuverable through the first portion and second portion andengageable with the first shoulder and second shoulder.
 14. Theinstrument according to claim 13, wherein the extension of the pusher isadapted to be engaged by a user.
 15. The instrument according to claim14, wherein the first grip and the second grip are adapted to be engagedby the user, wherein the first grip is adapted to be engaged by an indexfinger of the user and the extension and the second grip are eachindividually, and alternatively, adapted to be engaged by a thumb of theuser.
 16. The instrument according to claim 13, wherein the pusherfurther comprises a proximal portion extending from the lumen at aproximal end of the housing, the proximal portion being adapted to beengaged by a user.
 17. The instrument according to claim 16, wherein thehousing further comprising a third grip adapted to be engaged by theuser, wherein the third grip is adapted to be engaged by a middle fingerand a ring finger of the user or by an index finger and the middlefinger of the user, and the proximal portion is adapted to be engaged bya thumb of the user.
 18. The instrument according to claim 16, whereinthe housing further comprising a third grip adapted to be engaged by theuser, wherein the third grip is adapted to be engaged by at least onefinger of the user, and the proximal portion is adapted to be engaged bya thumb and an index finger of the user.
 19. A system for repairing ameniscus comprising: a suture assembly including a first anchor, asecond anchor, and a flexible suture connecting the first anchor and thesecond anchor, the flexible suture including a slide knot between thefirst anchor and the second anchor; and an inserter, comprising: aneedle having a longitudinal extending bore and an open distal end, thebore being configured to receive the first anchor and the second anchor;a housing operatively connected to a proximal end of the needle, thehousing having a lumen; a pusher configured to rotate and slide withinthe lumen of the housing and the longitudinal extending bore of theneedle; and a sheath releasably secured to the housing by a press-fitengagement and having a lumen, the needle being positionable within thelumen.
 20. The system according to claim 19, wherein the housingincludes a slot, the slot including a first portion, a second portion, afirst shoulder and a second shoulder, and the pusher having an extensionextending through the slot and configured to be maneuverable through thefirst portion and second portion and engageable with the first shoulderand second shoulder.
 21. The system according to claim 19, wherein theneedle includes a bend along a portion of its length and the sheath islinear along its length, and the lumen of the sheath having a diametersufficient to pass the bend of the needle therethrough.